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Responsibilities associated with this Associate Manager, Microbiologist are directly associated with interpreting microbiological testing data, monitoring, and maintaining the sterility assurance used in medical device manufacturing. The candidate must have experience interpreting and applying standards and regulations to medical device microbiological and sterility assurance control programs for the purposes of interpreting data, tactical planning on a daily basis, implementing procedures, and remediation projects.
The candidate must be a senior-level professional/team player with advanced knowledge and experience who thrives in a team environment but also has the capability to work alone to research and investigate. An understanding of clean room practice/cGMP and laboratory/GLP environments is required. The qualified candidate must understand the concepts of risk management as it relates to microbial monitoring and sterility assurance in a medical device manufacturing environment. This position reports into Global Laboratories and Sterility Assurance but will be located at an Integra manufacturing site.
Qualified candidates must possess relevant experience as a Microbiologist in one or more of the following areas and sufficient knowledge and experience to serve as a subject matter expert within one or more of the areas listed below.
• Controlled environment monitoring
• Water system monitoring
• Bacterial endotoxin test method validation and monitoring
• Bioburden test method validation and monitoring
• Radiation sterilization validation and dose audit management
SUPERVISION RECEIVED
Under direct supervision of Director, Microbiology.
SUPERVISION EXERCISED
This role will have a combination of direct and indirect supervisory responsibilities. Experience with complex project leadership and development of junior-level technical employees is preferred.
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty
Satisfactorily:
Generation and execution of microbial method validation protocols and reports including the writing, routing and approval of summary documentation.
Design experimental plans to address specific laboratory issues as needed.
Manage sample/testing processing with onsite and third-party labs, ensure timely testing and result reporting.
Ensure compliance of microbiology procedures, validations, and records with all company policies and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 11137, CMDR, Medical Device Directive, and USP.
Interpret microbiological data in order to identify trends and issues that require investigation.
Contribute to risk management activities including PFMEA generation.
Scheduling coordination, material allocation and alignment of personnel in order to successfully complete project assignments.
Create site procedures for microbiological testing and sampling in alignment with validations and in compliance with application regulations.
Mentors non-senior level microbiology staff.
Serve as Microbiology representative on cross-functional teams for transfer, NPI, and other projects as necessary, including supervision of contract resources.
Experience with Controlled environment monitoring, Water system monitoring, compressed air monitoring, Bacterial endotoxin test method validation and monitoring, Bioburden test method validation and monitoring, and radiation sterilization and dose audit management is preferred.
Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.
Support and address comments and suggestions associated with sterilization and microbiological test method validations and monitoring procedures.
Change control, non-conformance and CAPA support.
Support the department manager with providing direction to the team, coordinating work flow, and providing guidance in the resolution of problems or areas of concern
Participate in FDA inspections, ISO certifications, surveillance audits and customer audits.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
Minimum required education and experience: Bachelor degree or equivalent with 8+ years of experience, Master degree with 5+ years of experience, Doctoral degree with 3+ years of experience. Bachelor’s, or preferably Master of Science degree, in Microbiology or similar discipline.
Demonstrates excellent organizational and communication skills.
Results oriented with a strong focus on quality principles.
Excellent technical writing skills with an understanding of good documentation practice.
Experience conducting microbial test method validations and managing projects independently.
Experience creating and changing procedures used in operations for microbiological monitoring of the environment and products.
Working knowledge of applicable microbiology standards including, but not limited to, AAMI ST72, ISO 11737, ISO 14644, ISO 11137, and USP.
Ability to track milestones and manage projects.
Working knowledge of applicable regulations and their interpretation within industry.
Ability to travel up to 25%.
TOOLS AND EQUIPMENT USED
General office equipment: computers, printers, copiers, telephone communications equipment. Laboratory testing suppliers and equipment.
PHYSICAL REQUIREMENTS
The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.
While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak and can move throughout all locations of the building. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 25 pounds. Ability to travel via car, train and/or airplane to domestic and international locations as needed.
ADVERSE WORKING CONDITIONS
The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment.
Adverse exposure may result from the handling of hazardous and bio-hazardous materials that include, but are not limited to, flammable and corrosive liquids, compressed gases, sharps, and medical wastes.
SELECTION GUIDELINES
Formal application, rating of education and experience; oral interview and reference check; job related tests may be required.
DISCLAIMER
The duties listed above are intended only as illustrations of the various types of work that may be performed. The omission of specific statements of duties does not exclude them from the position if the work is similar, related, or a logical assignment to the position. The job description does not constitute an employment agreement between the employer and employee and is subject to change by the employer as the needs of the employer and requirements of the job change.
Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
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EEO Is the Law | EOE including Disability/Protected Veterans
Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.
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